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Thread: INVIVO Articles

  1. #31
    ....."Now that the first patient has been treated, InVivo will record the safety and efficacy data noted above at 24 hours, 48 hours, one week, time of hospital discharge, one month, three months, six months, and twelve months. InVivo will be working closely with the FDA on data analysis, and if the safety looks good at three months, then the trial will be cleared to allow enrollment of the second patient. After the second patient clears the three month safety assessment, the trial will be allowed to enroll the third patient, and so on and so forth until five patients are enrolled. As of now, we are not expecting the FDA to allow accelerated enrollment of patients 3-5 based on the safety and efficacy data from the first two patients, but that is certainly a possibility and something the company will aggressively pursue if the data looks good. Remember, this is an open-label study so the company, investors, and the general public (including the media) will be watching the recovery of this patient closely.However, assuming no accelerated enrollment, the pilot study will take 18 months to complete, with full twelve-month patient data on all five patients coming in roughly 28 to 30 months. Following successful completion of the pilot study, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE). We remind investors that InVivo received a Humanitarian Use Device (HUD) designation for the NSS in April 2013."

    .....

    http://seekingalpha.com/article/2564...ients?uprof=16

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  2. #32
    InVivo Therapeutics Announces Barnes-Jewish Hospital at Washington University as New Clinical Trial Site

    http://finance.yahoo.com/news/invivo...120000859.html

    InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Barnes-Jewish Hospital at Washington University Medical Center in St. Louis, MO, is the fourth clinical site in the company?s on-going IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Barnes-Jewish Hospital is the largest regional trauma center in St. Louis and is one of the largest clinical spine care practices for the United States. Paul Santiago, MD, an Associate Professor of Neurological Surgery and Orthopedic Surgery at the Washington University School of Medicine in St. Louis, will be the study?s Principal Investigator at the Barnes-Jewish Hospital.

    Dr. Santiago said, ?We look forward to participating in the evaluation of this novel treatment for acute spinal cord injury and hope that it we will be able to advance the treatment of patients with spinal cord injuries.?

    Mark Perrin, InVivo Chief Executive Officer, said, ?We are pleased that patient enrollment has begun and look forward to bringing more centers of excellence into our current pilot study. With Dr. Santiago and the Barnes-Jewish Hospital, we now have four sites that will be ready to enroll patients once we re-open enrollment. We have received IRB approval from two additional sites, which we will announce in the coming weeks after we complete the final administrative steps of site start-up.?

    This is the company?s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the U.S. Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  3. #33
    http://finance.yahoo.com/news/invivo...120000556.html

    InVivo Therapeutics Receives FDA Approval to Broaden Inclusion Criteria and Add 14 Additional Sites (20 Total) for Ongoing Pilot Trial
    Business Wire InVivo Therapeutics Holdings Corp.
    2 hours ago

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--

    InVivo Therapeutics Holdings Corp. (NVIV) today announced that the US Food and Drug Administration (FDA) has approved various changes to the protocol for the company’s ongoing IDE pilot trial for acute spinal cord injury (SCI), including expanding the number of allowable clinical sites to 20 (previously six) and broadening the eligibility criteria. With this approval, the upper end of the age range has been increased from 55 to 65, the spinal cord injury level has been expanded from T3-T11 to T3-T12/L1, the enrollment window has been extended from 10 to 21 days post injury, and the Body Mass Index upper limit has been increased from 35 to 39.

    Mark Perrin, InVivo’s CEO, said, “We have been working closely with the FDA to optimize enrollment for our acute SCI trial and are very pleased with this approval. We continue to take a proactive approach in broadening such critical variables to expedite subject enrollment.”

    For more information, please visit our ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110

    About InVivo Therapeutics

    InVivo Therapeutics Holdings Corp. is a pioneering biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

    8:20 am InVivo Therapeutics receives FDA approval to broaden inclusion criteria and add 14 additional sites (20 total) for ongoing pilot trial Briefing.com 2 hrs 30 mins ago
    INVIVO THERAPEUTICS HOLDINGS CORP. Files SEC form 8-K, Change in Directors or Principal Officers EDGAR Online 1 mth 0 days ago
    More
    About the Neuro-Spinal Scaffold

    The biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in a pilot study for the treatment of complete (AIS A) traumatic acute spinal cord injury.
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  4. #34
    http://finance.yahoo.com/news/invivo...130000534.html

    InVivo Therapeutics Announces University of Pittsburgh Medical Center Presbyterian as New Clinical Trial Site for Neuro-Spinal Scaffold
    Business Wire InVivo Therapeutics Holdings Corp.

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--

    InVivo Therapeutics Holdings Corp. (NVIV) today announced the University of Pittsburgh Medical Center (UPMC) Presbyterian in Pittsburgh, PA as a clinical site in the company’s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). UPMC is the largest non-governmental employer in Pennsylvania (with more than 62,000 employees) and operates more than 20 academic, community, and specialty hospitals and 400 outpatient sites. David Okonkwo, MD, PhD, is the Director of Neurotrauma and Director of Scoliosis and Spinal Deformity at UPMC Presbyterian and Associate Professor of Neurological Surgery and Clinical Director of the Brain Trauma Research Center at the University of Pittsburgh. Dr. Okonkwo will be the study’s Principal Investigator at that site.

    “We have been searching for decades for an option for patients with these challenging injuries,” Dr. Okonkwo said. “The InVivo study is a unique, never-before tried intervention for spinal cord injury. I’m excited to see if it will prove to be a new way of treating thoracic spinal cord injuries.”

    On October 15, 2014, InVivo announced enrollment of its first patient in the study at its clinical site, Barrow Neurological Institute in Phoenix, Arizona. Mark Perrin, InVivo’s CEO, said, “We’re very pleased to have Dr. Okonkwo and UPMC Presbyterian join our pilot trial. Dr. Okonkwo is a thought leader in this area and UPMC is a center of excellence in treating spinal cord injury patients and it is an honor to have them on board. We now have six sites that will be ready to enroll patients once we re-open enrollment.”

    This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the U.S. Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).

    For more information, please visit the Company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110

    Related Quotes
    NVIV
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    InVivo Therapeutics Holdings C … Watchlist
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    OTC Markets10:37 AM EST

    INVIVO THERAPEUTICS HOLDINGS CORP. Files SEC form 8-K, Regulation FD Disclosure EDGAR Online 5 days ago
    INVIVO THERAPEUTICS HOLDINGS CORP. Financials EDGAR Online Financials 6 days ago
    More
    About the Neuro-Spinal Scaffold

    The biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in a pilot study for the treatment of complete (AIS A) traumatic acute spinal cord injury.

    About InVivo Therapeutics

    InVivo Therapeutics Holdings Corp. is a pioneering biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  5. #35
    "According to an independent, early December 2014 interview with Jordan(which we have confirmed to be authentic), Jordan is making amazing progress. Feeling has returned to areas above his thighs, including some feeling to his penis; and he can now control his bowels and bladder. He states his goal is to, "Swing my leg over the seat of my motorcycle" in six months and to ultimately walk again. The most recent update as of December 22nd notes that Jordan is now able to, "Pivot his hips and move his legs through the water." Those are impressive results!"

    http://seekingalpha.com/article/2797975-15-biotech-names-for-2015?uide=9365621&uprof=16

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  6. #36
    Senior Member
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    First patient responds well to InVivo Spinal Scaffold

    The first acute spinal cord injury patient who received InVivo Therapeutics' (OTCQB:NVIV) Neuro-Spinal Scaffold has progressed from a complete AIS A injury to an incomplete AIS C injury with motor, sensory, bowel and bladder function improvements three months post implantation.
    http://seekingalpha.com/news/2232506...pinal-scaffold
    KB

  7. #37
    "He states his goal is to, "Swing my leg over the seat of my motorcycle" in six months"
    I love this guy. Let's go riding!

  8. #38
    Senior Member
    Join Date
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    Location
    Pakistan
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    That's good news

  9. #39
    Not good news at all for chronic SCI. But overall from a macro point of view it is great news. I think the patient only had a 10% chance of recovering to Asia C on his own. So if the next 2 patients recover to Asia C, it would be safe to say it works (assuming they're not cherry picking Asia A patients).

  10. #40
    Senior Member
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    Bloomfield Hills,MI
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    Quote Originally Posted by Nowhere Man View Post
    Not good news at all for chronic SCI. But overall from a macro point of view it is great news. I think the patient only had a 10% chance of recovering to Asia C on his own. So if the next 2 patients recover to Asia C, it would be safe to say it works (assuming they're not cherry picking Asia A patients).
    It may not be a bad thing for chronics.
    If the company can strike an alliance with a stem cell supplier and figure out how to seed the NSS with neural-spinal stem cells, then the market opens up from approximately 12,000 acute patients per year to some 300,000 chronic patients. That’s a 25-fold increase.
    http://finance.yahoo.com/news/nviv-i...180000161.html
    KB

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